Cleared Special

K992363 - SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN

K992363 · Euromed, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
28d
Days
-
Risk

K992363 is an FDA 510(k) clearance for the SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Euromed, Inc. (North Attleboro, US). The FDA issued a Cleared decision on August 12, 1999 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K992363

510(k) Number K992363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1999
Decision Date August 12, 1999
Days to Decision 28 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 664
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K992363.
ANTIBACTERIAL ADHESIVE BANDAGE
K992817 · William Feinstein & Associates, Inc. · Nov 1999
SILVERLON WOUND PACKING STRIPS
K984210 · Argentum International, LLC · Sep 1999
ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING
K990810 · Maersk Medical, Ltd. · Sep 1999
SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA
K991287 · Advanced Medical Solutions Group Plc · Jun 1999
DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING
K990891 · Dermaphylyx, Inc. · May 1999
DUMEX IODOFORM PACKING STRIP
K990332 · Dumex Medical Surgical Products, Ltd. · Apr 1999
K992363 · SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN
Download PDF FDA Summary Euromed, Inc.